Biosimilars Blog

By Michael S. Reilly, Esq. Executive Director, ASBM If a recent headline describing the biosimilar experience in Europe were to be believed, one would expect that biosimilars have captured a great deal of the biologics marketplace. The headline, “Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns” suggests these complex medicines are perfectly safe […]

Philip J. Schneider, MS FASHP Associate Dean, University of Arizona College of Pharmacy ASBM Advisory Board Chair This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice. The 5-hour […]

Harry L. Gewanter, MD, FAAP, FACR Chairman, ASBM Since becoming involved with ASBM on the Medical Advisory Board and, more recently, as Chairman, I’ve learned a great deal about biosimilars. Being a pediatrician, I have found that analogies are an extraordinarily helpful means to explain complex issues. This video has proven to be an […]

By Michael Reilly, Executive Director, ASBM To date, the FDA has approved three biosimilars. The first, Zarxio (filgrastim-sndz), used a meaningful, memorable suffix based on the manufacturers name (Sandoz). The second two use the random suffixes “-dyyb” and “-szzs” which mean, well, nothing. ASBM’s surveys have shown that physicians (78%) and pharmacists (85%) support memorable […]

A Picture is worth a thousand words… Why Memorable Names are preferred by Pharmacists by Philip Schneider, MS FASHP Associate Dean, University of Arizona College of Pharmacy ASBM Advisory Board Chair Yesterday, I was in Philadelphia with a group of about 50 pharmacy students and faculty speaking about biosimilars and the role they do play and […]

by Kenneth Fisher, MD Nephrologist, ASBM Advisory Board Member Biologic medicines are one of the most powerful tools physicians have to treat patients with serious conditions like cancer, rheumatoid arthritis, hepatitis, and multiple sclerosis. Copies of these therapies, called biosimilars, are becoming available in the U.S., and offer patients new treatment options, potentially at […]

By Philip Schneider, MS, FASHP ASBM Advisory Board Chair Having spent 40 years educating students, legislators, patients, and others about medications and pharmacy practice, I’ve learned that the key to changing minds is usually to get people to see things from a new, different angle. For example, as states grapple with how to handle […]

WASHINGTON, DC—In a letter to the FDA this week, a 70-group coalition of healthcare stakeholders including patient and provider organizations and others urged the use of distinguishable, meaningful suffixes for biosimilars. The letter to Leah Christl, Ph.D., FDA’s associate director for therapeutic biologics, comes on the heels of FDA’s departure from a meaningful to random […]

The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups — from patients to physicians, medical innovators, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.